Method and Apparatus for the Containment of a Surgical Site

ABSTRACT

An apparatus for the containment of a surgical site includes an enclosure, with at least one port, securely coupled to the surgical site and a source of pressurized fluid in fluid communication with the enclosure via the at least one port providing pressurized fluid to the surgical site. The pressurized fluid establishes a hemostatic equilibrium within the enclosure by reducing blood egress through injuries in blood vessels at the surgical site thereby preventing bleeding at the surgical site. A method for the containment of a surgical site includes securely coupling an enclosure to a surgical site; fluidly coupling a source of pressurized fluid to the enclosure; and continuously providing pressurized fluid to the enclosure from the source of pressurized fluid and draining fluid from the enclosure. The pressurized fluid establishes a hemostatic equilibrium within the enclosure.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 60/858,570 entitled “Method and Apparatus for theContainment of a Surgical Site” filed Nov. 13, 2006, which is herebyincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates, in general, to the containment of asurgical site and, more specifically, to the containment of a surgicalsite through the use of a fluid filled enclosure.

2. Description of Related Art

Intraoperative bleeding and its subsequent control are definingcharacteristics of most surgical procedures. The occurrence ofunintended or uncontrollable hemorrhage during the course of a surgicalprocedure is an uncommon but dangerous event. Such hemorrhage may be dueto a vessel wall defect, pathological vasculature, surgicalmisadventure, trauma or surgical release of a damaged vessel staunchedby regional tissue pressure. Although most of these situations can beultimately controlled, such hemorrhage may lead to seriouscomplications. Specific situations include, but are not limited to,hemorrhage due to a vessel lesion such as a cerebral aneurysm, vesselrupture remote from a minimally invasive exposure, vessel rupture priorto adequate exposure, ruptured pathologic vessels such as an aorticaneurysm, an arteriovenous malformation, trauma, vascular tumors, etc.In these situations, blood flow interruption may result in tissueinfarction or, in severe circumstances in which blood loss cannot bestopped, exsanguination and death.

Even non-fatal surgical hemorrhage has a variety of other negativeimpacts. For instance, after approximately a half liter of blood loss,intravascular hypovolemia begins to manifest as hypotension andtachycardia. This routinely necessitates volume replacement andoccasionally blood product administration. Hemorrhage also obscuressurgical anatomy. Accordingly, hemorrhage (or even the possibility ofit) requires the surgeon's constant attention. Blood evacuation andintraoperative hemostasis routinely requires significant portions of thesurgeon's time and attention, thereby diverting his or her attentionfrom the actual procedure. While this prolongation of the procedure timeis usually of little consequence, the obscuration of surgical anatomydue to innocuous bleeding may ultimately affect the efficiency andquality of the results.

During any surgical procedure, a patient will typically experience aslow, but steady, loss of blood through tissue blood vessel injuriesthrough the normal course of dissection. While such blood loss does notpose the threat to the patient that surgical hemorrhage caused by aruptured artery does, such blood loss may affect the efficiency of thesurgeon because he or she must divert his or her attention from thesurgical procedure. Furthermore, this slow seepage of blood into thesurgical site obstructs the surgeon's view of the patient's anatomythereby making the surgical procedure more difficult. Moreover, someblood loss has been unavoidable in most surgical procedures, and it istherefore easy to lose sight of the ideal of no blood loss.

Currently, a variety of methods are employed to control bleeding duringsurgical problems. The methods utilized are usually situation specific.In certain circumstances, low-level continuous hemorrhage may be allowedto continue during the surgical procedure, only to be staunched at theend. However, in most cases, efforts to maintain hemostasis (i.e.,elimination of bleeding) are applied throughout the procedure.Accordingly, techniques have evolved within the various surgicaldisciplines to deal with surgical hemorrhage. For instance, manualcompression, or tamponade, is an effective hemostatic maneuver. Thismethod elevates the tissue pressure in the area of the hemorrhagethereby occluding the egress route of the blood. This method suffersfrom various drawbacks. For instance, this method also compromiseshealthy tissue perfusion so it is rarely useful as a permanent solution.Another method of minimizing bleeding and diminishing blood loss is theocclusion of the vascular pedicle of a hemorrhaging organ. However, thismethod leads to even greater perfusion compromise than tamponade does.Surgeons also implement microsurgical vessel repair to minimize bleedingwhen the injury is apparent and the exposure is sufficient. Surfacecautery is another very popular means of controlling small vesselhemorrhage. Additionally, surgeons may use clamps and cauterization tominimize bleeding. However, each of these methods also suffers fromvarious drawbacks.

Currently, there are instances in which orthopedic surgeons utilizeuncontained pressurized fluid in certain surgical procedures. Forinstance, a joint can be infused with fluid in order to open the spacefor inspection and for manipulation. As an unintended side effect ofsuch an application of fluid, it has been observed by orthopedicsurgeons that bleeding is reduced due to the wound exposure to the fluidunder pressure. However, in the course of an arthroscopic surgicalprocedure utilizing such fluid application, large quantities of salinesolution tend to escape and typically run onto the operating room floor,notwithstanding attempts to collect the flow by using towels or plasticsheets draped in various ways. Depending on the type of operation andits duration, a large quantity of saline solution is lost. It is notuncommon to use between one to eight two-liter bags of saline solutionduring the course of a surgical procedure of this type.

Accordingly, although hemorrhage is a commonly encountered aspect ofsurgery, it diverts time and attention from the aim of the procedure andcan occasionally be catastrophic. A need exists for an easy, safe andeffective means to control and stop bleeding associated with surgicalinterventions.

SUMMARY OF THE INVENTION

In order to meet this need, the present invention is a surgical sitecontainment device and method that utilizes a contained fluid deliveredunder controlled, elevated pressure to an enclosure to obtain ahemostatic equilibrium at the surgical site. Such equilibrium isachieved when a fluid is delivered to a surgical site at a pressure thatis elevated to the extent necessary to staunch flow out of rent, torn orotherwise opened blood vessels, veins, capillaries, arterioles, venulesand arteries thereby minimizing or stopping bleeding at the surgicalsite.

The present invention is more particularly directed to an apparatus forthe containment of a surgical site and to apply contained, pressurizedfluid to the surgical wound, and allowing surgical manipulation toproceed through the container and the contained fluid. The apparatusincludes an enclosure, with at least one port, securely coupled to thesurgical site, and a source of pressurized fluid, in fluid communicationwith the enclosure via the at least one port providing pressurized fluidto the surgical site. The pressurized fluid establishes a hemostaticequilibrium within the enclosure by reducing blood egress throughinjuries in blood vessels at the surgical site, thereby minimizing orpreventing bleeding at the surgical site.

The enclosure may include at least a first port, or a first port and asecond port. The first port may be configured to be in communicationwith the source of pressurized fluid and the second port may be adaptedto provide an outlet for the pressurized fluid. The enclosure mayfurther include a third port adapted to receive a surgical tool thereinand a fourth port adapted to receive optical devices therein. However,this is not to be construed as limiting the present invention as thenumber of ports corresponds to the number of entry points required bythe tools necessary to perform the specific operation. If necessary,pressurized fluids (in and out) and all surgical tools may pass througha single port.

The enclosure may be constructed from aluminum, titanium or a polymersuch as, but not limited to, polyethylene terephthalate, polyacrylate,polyurethane, or polycarbonate. At least a portion of the enclosure maybe constructed from a transparent material thereby allowing a surgeon tosee inside of the enclosure, or the enclosure may include a windowformed therein to allow a surgeon to see inside the enclosure. Theenclosure may be securely coupled to the surgical site via an adhesive,a pressure loaded device and/or gasket, a robotic arm or any combinationthereof. The enclosure may further include at least one tool port. Theat least one tool port may be sized to accommodate one or more surgicaltools.

The pressurized fluid may be continuously delivered to the enclosure ata pressure of about 1 to 300 torr above ambient atmospheric pressure.The surgical site may be a patient's knee, abdomen, brain, spine,thoracic cavity, shoulder, elbow, wrist or any combination thereof.

The present invention is also directed to a method for the containmentof a surgical site. The method includes the steps of securely couplingan enclosure to a surgical site; fluidly coupling a source ofpressurized fluid to the enclosure; and continuously providingpressurized fluid to the enclosure from the source of pressurized fluidand draining fluid from the enclosure. The pressurized fluid establishesa hemostatic equilibrium within the enclosure by reducing blood egressthrough injuries in blood vessels at the surgical site, therebypreventing bleeding at the surgical site.

An alternative embodiment of the apparatus for containment of a surgicalsite may include an enclosure securely coupled to the surgical site, atleast one sensor positioned within the enclosure for providing signalsindicative of a condition within the enclosure, a source of pressurizedfluid in fluid communication with the enclosure providing pressurizedfluid to the surgical site and a control device electronically coupledto the source of pressurized fluid and the at least one sensor. Theenclosure includes at least a first port adapted to provide an inlet fora pressurized fluid, a second port adapted to provide an outlet forfluids containing reusable blood cells and/or waste materials, a thirdport adapted to receive a surgical tool therein and a fourth portadapted to receive optical devices therein. The control device isconfigured to control the source of pressurized fluid based on signalsprovided by the at least one sensor. The pressurized fluid establishes ahemostatic equilibrium within the enclosure by reducing blood lossthrough injuries in blood vessels at the surgical site, therebypreventing bleeding at the surgical site.

These and other features and characteristics of the present invention,as well as the methods of operation and functions of the relatedelements of structures and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. As used in the specification and the claims, thesingular form of “a”, “an”, and “the” include plural referents unlessthe context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an apparatus for the containment of asurgical site and a surgical site prior to coupling the apparatus to thesurgical site in accordance with the present invention;

FIG. 2 is a perspective view of the apparatus for the containment of thesurgical site after the apparatus has been securely coupled to thesurgical site for the containment of the surgical site;

FIG. 3 is a cross-sectional view of the apparatus of FIG. 2;

FIG. 4 is a schematic diagram of the apparatus for the containment ofthe surgical site;

FIG. 5 is an alternative embodiment of the apparatus for the containmentof the surgical site in accordance with the present invention;

FIG. 6 is a perspective view of the head of a patient having an opensurgical site;

FIG. 7 is a perspective view of the head of a patient having anotheralternative embodiment of the apparatus for the containment of thesurgical site coupled thereto; and

FIG. 8 is a perspective view of the head of a patient having thealternative embodiment of the apparatus for the containment of thesurgical site of FIG. 7 coupled thereto after a flap of the skin hasbeen positioned over the apparatus.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal” and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

The present invention is directed to a method and apparatus for thecontainment of a surgical site. The method and apparatus utilizespressure from a physiological fluid to establish a hemostaticequilibrium within an enclosure that surrounds the surgical site. Ahemostatic equilibrium is achieved when the fluid pressure reduces bloodloss caused by injuries in blood vessels at the surgical site therebypreventing bleeding at the surgical site. Injuries in blood vesselsinclude, but are not limited to, tears, rents, or any other opening in ablood vessel. When such injuries occur, blood seeps into the surgicalsite. The application of a fluid pressure to these injuries that isslightly greater than the pressure of the blood seeping from the injuryforces the blood to continue flowing through the blood vessel instead offlowing out of the injury. In this manner, a hemostatic equilibrium isestablished. The method and apparatus of the present inventionadvantageously allows the surgeon to perform a surgical procedure in asubstantially blood free environment thereby enhancing clarity of thesurgical site and allowing the surgeon to concentrate on the surgicalprocedure at hand rather than the cessation of bleeding.

Additionally, the apparatus of the present invention may be used bothbefore and after a surgical procedure as well as during a surgicalprocedure. For instance, an emergency medical technician (EMT) may placethe apparatus of the present invention over a wound of a patient inorder to stop the wound from bleed until a surgeon can perform asurgical procedure. Furthermore, after a surgical procedure has beenperformed, the surgeon may leave the apparatus of the present inventionon the surgical site for extended periods when no surgery is beingperformed to reduce swelling, maintain hemostasis, cleanse the surgicalsite or fight infection. Accordingly, as used herein, a surgical site isany open wound on any part of the body of a patient.

For purposes of illustration, the present invention will be describedhereinafter in relation to a neurosurgical procedure. However, this isnot to be construed as limiting the present invention, as the use of thepresent invention with any type of surgical procedure has beenenvisioned. For instance, the surgical site may be a patient's knee,abdomen, spine, thoracic cavity, shoulder, elbow, wrist or any otherappropriate surgical site.

With reference to FIGS. 1-4, an apparatus 1 for the containment of asurgical site 3 includes an enclosure 5 with a base portion 7 configuredto be securely coupled to the patient 8 around surgical site 3, and aviewing portion 9. Enclosure 5 may be constructed from any suitablematerial including, but not limited to, aluminum, titanium or apolymeric material such as, but not limited to, polyethyleneterephthalate, polyacrylate, polyurethane, or polycarbonate, and may berigid or flexible. Enclosure 5 may be constructed either entirely from atransparent material, may include a transparent view window or may beconstructed entirely from an opaque material with a port for a camera,endoscope, microscope or a fiber optic imaging device. Enclosure 5 mayalso be any suitable shape and size depending on the surgical procedurethat is being performed. For instance, enclosure 5 may be much larger ifa surgery is being performed on a patient's back than if the surgery isbeing performed on a patient's head.

Enclosure 5 further includes a plurality of ports positioned thereon.For instance, enclosure 5 may include a first port 11 adapted to providean inlet for a pressurized fluid, a second port 13 adapted to provide anoutlet for fluids and/or waste materials, a third port 15 adapted toreceive a surgical tool 17 therein and a fourth port 19 adapted toreceive optical devices 21 therein. Optical devices 21 may include, butare not limited to, fiber optic imaging devices, cameras, lightingdevices and the like. While enclosure device 5 was described hereinabove as including four ports, this is not to be construed as limitingas any appropriate number of ports have been envisioned. For instance,additional ports 22 (shown in phantom in FIG. 3) may be provided onenclosure 5 to allow access inside enclosure 5 for any tools necessaryto perform a surgical procedure. Accordingly, the number of portscorresponds to the number of entry points required by the toolsnecessary to perform the specific operation. Furthermore, the size andshape of the ports may vary depending on the type of tool or instrumentthat is passing into enclosure 5. Additionally, the ports may be sizedto accommodate one or more tools passing therethrough into enclosure 5.

Apparatus 1 also includes at least one sensor 23 coupled to enclosure 5for providing signals indicative of a condition within enclosure 5, afluid reservoir and pumping system 25 in fluid communication withenclosure 5 for providing pressurized fluid to surgical site 3 and acontrol unit 27 coupled to fluid reservoir and pumping system 25 and theat least one sensor 23.

The at least one sensor 23 may be any suitable device for determiningthe condition within enclosure 5. Sensor 23 may be as simple as a seriesof observations taken by the surgeon of the clarity of the fluid withinenclosure 5 and control unit 27 may be a switch, foot pedal, dial orother suitable device for adjusting the pressure of the fluid providedby fluid reservoir and pumping system 25 to enclosure 5. Among the morecomplex embodiments, sensor 23 may be a colorimetric sensor, a pressuresensor and/or an oxygen saturation monitor, and control unit 27 may be amicroprocessor or microcontroller. Control unit 27 may further include afine manual control device (not shown). During the course of routinesurgery, small vessel bleeding may occur that the surgeon wishes toimmediately and permanently stop. The fine manual control device ofcontrol unit 27 provides the surgeon with the capacity to elevate thepressure just to the point of hemostasis in such cases.

In situations where a colorimetric sensor is used as sensor 23, thecolorimetric sensor determines whether the fluid within enclosure 5 isany color other than clear. The fluid may have a color other than clearif it is mixed with blood from the wound opening. If the sensordetermines that the fluid within enclosure 5 is colored, a signal issent to control unit 27 to flush enclosure 5 with fluid from fluidreservoir and pumping system 25 until the colorimetric sensor indicatesthat the fluid within enclosure 5 is clear. The fluid from fluidreservoir and pumping system 25 enters enclosure 5 via first port 11 andthe fluid mixed with blood and/or other waste materials exit throughsecond port 13.

In situations where an oxygen saturation monitor is utilized as sensor23, the oxygen saturation monitor is positioned in a portion of thepatient's wound and determines the percentage of the patient's bloodthat is saturated with oxygen. Normally, the patient's blood should be100% saturated with oxygen. When the pressure of the fluid provided atthe wound site is too great, the pressure of the fluid will embarrassperfusion thereby preventing oxygen from reaching the tissue and bloodvessels at the wound site. Such a condition may be harmful to thepatient. Therefore, if the pressure of the fluid oxygen saturation ofthe patient's blood falls below a certain predetermined threshold level,such as 95%, the oxygen saturation monitor will send a signal to controlunit 27 indicating that the pressure of the fluid being supplied toenclosure 5 should be decreased. Control unit 27 then decreases thepressure of the fluid either autonomously or under control of thesurgeon by sending a signal to fluid reservoir and pumping system 25.

In situations where a pressure sensor is utilized as sensor 23, apressure sensor is provided at the inlet of first port 11 and measuresthe ambient pressure of the fluid in the enclosure 5. A signalindicative of the pressure is then sent to control unit 27 by thepressure sensor. Control unit 27 may then display the pressure of thefluid on a display 29. The surgeon will then be able to monitor thepressure of the fluid by watching display 29 and adjust the pressurewith a user interface (not shown). Display 29 may be any suitabledisplay device such as, but not limited to, a cathode-ray tube display,a liquid crystal display, a plasma display or the like.

While the present invention has been described hereinabove as having asensor 23 embodied as either a colorimetric sensor, a pressure sensor oran oxygen saturation monitor, this is not to be construed as limitingthe present invention as the use of any other appropriate type of sensoror a combination of the above described sensors has been envisioned foruse as sensor 23.

Fluid reservoir and pumping system 25 is designed to introduce apressurized fluid to enclosure 5. The pumping system may be any suitablepumping device including, but not limited to, a manometric column, apressure bag, a roller pump, a foot pump, a pulsatile pump or the like.The pressurized fluid is delivered from the fluid reservoir and pumpingsystem 25 through standard medical tubing to first port 11 of enclosure5. Excess fluid and waste are returned to a fluid reservoir through apiece of medical tubing fluidly coupled to second port 13 of enclosure5. Prior to being returned to the fluid reservoir, the excess fluid andwaste may be filtered by a filter 31 thereby allowing the fluid to berecirculated. Filter 31 may be any appropriate filter such as, but notlimited to, a porous filter, a cyclonic filter or the like. Red bloodcells may be harvested from the waste fluid and reused. Filtered wastefluid may be reused or discarded.

The fluid provided by fluid reservoir and pumping system 25 may be, butis not limited to, a physiological saline solution, syntheticcerebrospinal fluid (CSF), or the like. Antibiotic agents may be addedto the fluid to prevent infection. Also, vocative agents, such asepinephrine, may also be added to the fluid to constrict blood vessels.

In operation, the area of the body where the surgery is to be performedis covered first with an antibacterial plastic adhesive sheet throughwhich an incision is made thereby creating surgical site 3. Next,enclosure 5 is positioned over surgical site 3 and sealed to patient 8via an adhesive 33. Adhesive 33 could also be a gasket of anintrinsically self-sealing and removable material such as, but notlimited to a soft or elastic polymer. After the initial incision is madeand enclosure 5 is securely coupled to surgical site 3, a pressurizedfluid is pumped into enclosure 5 via first port 11 at an increasingpressure. The pressure at which the fluid is provided to enclosure 5 isdesirably equivalent to the pressure of the blood at the ends of theexposed blood vessels, capillaries and arteries. The achievable pressureis from about 10 ton to about 300 torr. Very low pressures will stopminor bleeding from arterioles and capillaries. The fluid iscontinuously flushed from enclosure 5 until a clear environment isestablished in enclosure 5. Any waste materials and fluid mixed withblood are flushed from enclosure 5 via second port 13 as discussedhereinabove. The fluid is flushed from enclosure 5 and the environmentwithin enclosure 5 clears. Hemostatic equilibrium is thereby establishedwithin enclosure 5 allowing surgical site 3 to remain blood free duringthe remainder of the procedure. The surgeon can then perform a surgicalprocedure using surgical tool 17 and any other tools. The pressure ofthe fluid being supplied to enclosure 5 is monitored using the at leastone sensor 23, as discussed hereinabove, during the surgical procedure.

While the use of an adhesive was described hereinabove as securelycoupling enclosure 5 to surgical site 3, this is not to be construed aslimiting, as the use of any device for securely coupling enclosure 5 tosurgical site 3 has been envisioned. For instance, a pressure loadeddevice, a robotic arm or temporary suturing may be used to securelycouple enclosure 5 to surgical site 3.

With reference to FIG. 5, an alternative embodiment of an apparatus forcontaining a surgical site is illustrated. This apparatus 1′ includes anenclosure 5′ with a base portion 7′ configured to be securely coupled tothe patient around surgical site 3′, and a viewing portion 9′. Enclosure5′ may be constructed from any suitable material including, but notlimited to, aluminum, titanium or a polymeric material such as, but notlimited to, polyethylene terephthalate, polyacrylate, polyurethane, andpolycarbonate, and may be rigid or flexible. Enclosure 5′ may beconstructed either entirely from a transparent material or may include atransparent view window 35. Enclosure 5′ may also be any suitable shapeand size depending on the surgical procedure that is being performed.For instance, enclosure 5′ may be much larger if a surgery is beingperformed on a patient's back than if the surgery is being performed ona patient's head.

Enclosure 5′ further includes a single inlet/outlet port 37.Inlet/outlet port 37 allows fluid to enter enclosure 5′ and allows fluidto be flushed from enclosure 5′. This embodiment is desirable forsituations where the patient has an open surgical site 3′ for extendedperiods of time and when the invention is utilized in the post-operativeperiod. The patient may have an open surgical site covered by enclosure5′ for extending periods when no surgery is being performed to reduceswelling, maintain hemostasis, cleanse the surgical site or fightinfection. In instances where it is necessary to cleanse a surgicalsite, enclosure 5′ is irrigated at a higher flow than would generally beused during routine procedures. This cleansing could eliminate largeclots, foreign material introduced during trauma, or spillage fromintestinal injury in the abdomen. A measured amount of adjuvant materialsuch as, but not limited to, antibiotics, surfactants, anticoagulants,etc. might be included in such cleansing procedures.

Another embodiment of the present invention utilizes an enclosure thatis formed from a cavity of a patient's body. For instance, the conceptsof the present invention may be utilized in laparoscopic surgeries.Laparoscopic surgery is a surgical technique for performing surgicalprocedures on the abdomen or pelvic cavity. Laparoscopic surgeryincludes making a first small incision on a patient's abdomen andinserting a Hopkins rod lens system connected to a video camera therein.A second small incision is made for a fiber optic cable system connectedto a ‘cold’ light source, such as a halogen or xenon bulb, to illuminatethe operative field. Additional incisions may be made to introducesurgical tools. In a conventional laparoscopic surgery, the abdomen isusually insufflated with carbon dioxide gas to create a working andviewing space. The present invention, rather than insufflating theabdominal cavity with carbon dioxide gas, provides a pressurized fluidto the abdominal cavity via an additional incision. The pressure of thefluid is increased until the surgeon views a cavity that is cleared.Excess fluid and waste fluid may be drained through the same incision oran additional incision.

With reference to FIGS. 6-8, an additional embodiment of the presentinvention may be used during a decompressive craniectomy procedure.Decompressive craniectomy is a surgical procedure in which part of theskull is removed to allow a swelling brain room to expand without beingsqueezed. It is performed on victims of traumatic brain injury. As shownin FIG. 6, a decompressive craniectomy begins with the surgeonretracting a portion of the scalp 37 of a patient 8. Thereafter, a partof the skull is removed by the surgeon (not shown) to produce a surgicalsite 3″. The part of the skull that is removed is commonly referred toas a bone-flap.

Thereafter, and with reference to FIG. 7, an enclosure 5″ of theapparatus for the containment of a surgical site 31 is positioned oversurgical site 3″ and sealed to patient 8 via an adhesive 33 or any othersuitable means. Enclosure 5″ is sized and shaped to correspond to theportion of scalp 37 of the patient 8 that has been retracted. Enclosure5″ includes an inlet port 39 adapted to provide an inlet for apressurized fluid and an outlet port 41 adapted to provide an outlet forfluids and/or waste materials. Inlet port 39 is coupled to a fluidconduit 43 for providing a pressurized fluid to surgical site 3″ andoutlet port 41 is coupled to a fluid conduit 45 that provides an outletfor fluids and/or waste material. Fluid conduits 43, 45 are coupled to afluid reservoir and pumping system (not shown) as discussed hereinabovewith reference to FIG. 4. The apparatus further includes sensors 23″positioned on enclosure 5″ and coupled to a control unit 27″ formonitoring enclosure 5″ as discussed hereinabove. Sensors 23″ may be,but are not limited to, colorimetric sensors, pressure sensors or oxygensaturation monitors.

Enclosure 5″ is configured to stay on surgical site 3″ chronically untilbrain swelling has been reduced. Accordingly, and with reference to FIG.8, once enclosure 5″ is properly coupled to surgical site 3″ and fluidsare properly provided to and removed from enclosure 5″ via inlet port 39and outlet port 41, respectively, the surgeon may position the portionof scalp 37 that has been retracted and suture the portion of scalp 37back to the head of patient 8 thereby completely covering enclosure 5″of the apparatus. The fluids provided to enclosure 5″ wash out cells andnecrotic factors from surgical site 3″. In addition, the fluid providesmodest hemostatic functions.

In addition to enclosure 5″, enclosure 5 as described in FIGS. 1-3 mayalso be used for a decompressive craniectomy by sealing third port 15and fourth port 19.

A further variation on the disclosure, above, includes making thelocation of one or more access ports flexible and/or adaptable in anyway feasible. For example, the large dome structure of FIG. 5 may bemade from a flexible material, rather than a rigid material, so that anyaccess means or one or more ports in the dome can be moved by thesurgeon (or other health care practitioner) to a desired locationwithout being rigidly constrained to a particular location ororientation in the overall device. Clearly, a surgeon has to have accessto the surgical site within the present device with minimal or no toolpositioning constraint. Additional variations, along this same portlocation flexibility theme, can include, without limitation, movablegrids, expansible or stretchable ports or zipper-like or track-likeconstructs which allow the containment area to be customized on the spotas to the insertion location for one or more tools via one or moreports. It should be noted that in all embodiments of the invention butespecially in any embodiment including one or more elastomeric orotherwise moveable or expansible/contractile walls, it is important tohave in place an appropriate feedback control mechanism to maintainfluid pressure at the desired level to counteract the otherwiseinevitable pressure changes which such elastomericity and/or movementwould create.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements. Furthermore, it is to beunderstood that the present invention contemplates that, to the extentpossible, one or more features of any embodiment can be combined withone or more features of any other embodiment.

1. An apparatus for the containment of a surgical site comprising: anenclosure, with at least one port, securely coupled to the surgicalsite; and a source of pressurized fluid in fluid communication with theenclosure via the at least one port providing pressurized fluid to thesurgical site; wherein the pressurized fluid establishes a hemostaticequilibrium within the enclosure by reducing blood egress throughinjuries in blood vessels at the surgical site thereby preventingbleeding at the surgical site.
 2. The apparatus of claim 1, wherein theenclosure includes at least a first port and a second port.
 3. Theapparatus of claim 2, wherein the first port is configured to be incommunication with the source of pressurized fluid and the second portis adapted to provide an outlet for the pressurized fluid.
 4. Theapparatus of claim 2, wherein the enclosure further includes a thirdport adapted to receive a surgical tool therein and a fourth portadapted to receive optical devices therein.
 5. The apparatus of claim 1,wherein the enclosure is constructed from aluminum, titanium,polyethylene terephthalate, polyacrylate, polyurethane, polycarbonate orany combination thereof.
 6. The apparatus of claim 1, wherein at least aportion of the enclosure is constructed from a transparent materialthereby allowing a surgeon to see inside of the enclosure.
 7. Theapparatus of claim 1, wherein the enclosure comprises a window formedthereon allowing a surgeon to see inside the enclosure.
 8. The apparatusof claim 1, wherein the enclosure is securely coupled to the surgicalsite via an adhesive, a pressure loaded device, a robotic arm or anycombination thereof.
 9. The apparatus of claim 1, wherein thepressurized fluid is continuously delivered to the enclosure at apressure of about 1 torr to 300 torr above ambient atmospheric pressure.10. The apparatus of claim 1, wherein the surgical site is a patient'sknee, abdomen, brain, spine, thoracic cavity, shoulder, elbow, wrist orany combination thereof.
 11. The apparatus of claim 1, wherein theenclosure further comprises at least one tool port.
 12. The apparatus ofclaims 11, wherein the at least one tool port is sized to accommodateone or more surgical tools.
 13. A method for the containment of asurgical site comprising the steps of: a) securely coupling an enclosureto a surgical site; b) fluidly coupling a source of pressurized fluid tothe enclosure; and c) continuously providing pressurized fluid to theenclosure from the source of pressurized fluid and draining fluid fromthe enclosure, wherein the pressurized fluid establishes a hemostaticequilibrium within the enclosure by reducing blood egress throughinjuries in blood vessels at the surgical site thereby preventingbleeding at the surgical site.
 14. The apparatus of claim 13, whereinthe enclosure includes at least a first port and a second port.
 15. Themethod of claim 14, wherein the first port is configured to be incommunication with the source of pressurized fluid and the second portis adapted to provide an outlet for the pressurized fluid.
 16. Themethod of claim 14, wherein the enclosure further includes a third portadapted to receive a surgical tool therein and a fourth port adapted toreceive optical devices therein.
 17. The method of claim 13, wherein theenclosure is constructed from aluminum, titanium, polyethyleneterephthalate, polyacrylate, polyurethane, polycarbonate or anycombination thereof.
 18. The method of claim 13, wherein at least aportion of the enclosure is constructed from a transparent materialthereby allowing a surgeon to see inside of the enclosure.
 19. Themethod of claim 13, wherein the enclosure is securely coupled to thesurgical site via an adhesive, a pressure loaded device, a robotic armor any combination thereof.
 20. The method of claim 13, wherein thepressurized fluid is continuously delivered to the enclosure at apressure of about 1 torr to 300 ton above ambient atmospheric pressure.21. The method of claim 13, wherein the surgical site is a patient'sknee, abdomen, brain, spine, thoracic cavity, shoulder, elbow, wrist orany combination thereof.
 22. An apparatus for the containment of asurgical site comprising: a) an enclosure securely coupled to thesurgical site, the enclosure comprising at least: i) a first portadapted to provide an inlet for a pressurized fluid; ii) a second portadapted to provide an outlet for fluids and/or waste materials; iii) athird port adapted to receive a surgical tool therein; and iv) a fourthport adapted to receive optical devices therein; and b) at least onesensor positioned within the enclosure for providing signals indicativeof a condition within the enclosure; c) a source of pressurized fluid influid communication with the enclosure via the first port, the source ofpressurized fluid thereby providing pressurized fluid to the surgicalsite; and d) a control device electronically coupled to the source ofpressurized fluid and the at least one sensor, the control deviceconfigured to control the source of pressurized fluid based on signalsprovided by the at least one sensor, wherein the pressurized fluidestablishes a hemostatic equilibrium within the enclosure by reducingblood loss through injuries in blood vessels at the surgical sitethereby preventing bleeding at the surgical site.